Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions and Status of the Claims
Applicant’s election of
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as the ‘single compound,’ is acknowledged. Claims 1-2, 4, 8, 10-13, 17-18, 20-21, 25-26, 31-32, 36-37, 41-42, 45-46, and 65 are pending. Claims 2, 11-13, 17-18, 20-21, 25-26, 31-32, 36-37, 41-42, 45-46, and 65 are withdrawn as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 4, 8, and 10 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on August 11th 2025 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 102(a)(1) Rejections Overcome by Argument
Applicant’s arguments in the response filed on August 11th 2025 are acknowledged. Applicant argues that the instant compound genus requires the presence of both the R and R1 substituents, in contrast to the singly-substituted aryl ring of Schupan’s compounds. Schupan therefore does not anticipate the compounds of claim 1 and the 102 rejections over claims 1, 4, and 10 are withdrawn.
35 U.S.C. § 103 Rejections Maintained
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The rejection of claim 8 under 35 U.S.C. 103 as being unpatentable over Schuppan (WO 2004/058234 A2) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012) is maintained.
Response to Applicants Arguments:
Applicant’s argument in the response filed on August 11th 2025 is acknowledged. Applicant argues that
No motivation to modify Schuppan’s compound 8 exists because the compound is not identified as one of the most potent compounds.
Schuppan ‘teaches away’ compound 8 with the statement that compounds wherein R2 are hydrogen are most preferred.
Applicant’s argument is found not persuasive. Regarding the claim that Schuppan teaches away from compound 8, Schuppan does not provide any indication that a substituted R2 group is inferior to the other compounds, but only states that compounds containing an R2 hydrogen are of special interest. Furthermore, the same paragraph (Schuppan, pg. 41) indicates that the pyridyl group (relevant to applicant’s compound 8) is of the same interest. Schuppan’s remarks do not constitute a ‘teaching away,’ but only an indication of an interest in particular compounds. See MPEP 2145:
“Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.")”
Regarding applicant’s claim that there is no motivation to modify compound 8, applicant does not argue that the described modifications to compound 8 would not be expected to result in an HDAC inhibitor of similar activity to those of Schuppan, but only that one would not choose compound 8 as a reasonable starting point. In this regard, it is argued that one of ordinary skill in the art would reasonably expect applicant’s compound to share properties with Schuppan’s compound 8 because of the strong similarities between compound 8 (a known HDAC inhibitor) and applicant’s compound (described in the 103 rejection below). See MPEP 2143:
“Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound. . . . In keeping with the flexible nature of the obviousness inquiry, the requisite motivation can come from any number of sources and need not necessarily be explicit in the art. Rather "it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently close relationship . . . to create an expectation,’ in light of the totality of the prior art, that the new compound will have ‘similar properties’ to the old." Id. at 1357, 87 USPQ2d at 1455.”
“The Federal Circuit in Eisai makes it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound: "Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound." Eisai, 533 F.3d at 1357, 87 USPQ2d at 1455. Thus, Office personnel should recognize that a proper obviousness rejection of a claimed compound that is useful as a drug might be made beginning with an inactive compound, if, for example, the reasons for modifying a prior art compound to arrive at the claimed compound have nothing to do with pharmaceutical activity. The inactive compound would not be considered to be a lead compound by pharmaceutical chemists, but could potentially be used as such when considering obviousness.”
As the following 103 rejection over claim 8 is over applicant’s elected species of Formula III, the rejection is thus applicable to claims 1, 2, 4, and 10, which each read on the elected species (Note: Claim 10 is directed towards a pharmaceutical composition of the compound of claim 1. Schuppan teaches pharmaceutical compositions of the compound (Schuppan, pg. 246, claim 46)).
35 U.S.C. § 103 Rejections Reiterated
Claim 8 requires that the compound of claim 1 is:
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Schuppan teaches compound 8:
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(Schuppan, pg. 51, compound 8).
Schuppan’s compound 8 differs from applicant’s compound in the substitution of a phenyl for applicant’s pyridine and a substitution of a hydrogen for applicant’s fluorine. One of ordinary skill in the art would reasonably develop applicant’s compound from Schuppan’s compound 8, because both substitutions are common bioisosteric substitutions in the field of drug discovery. See Brown, who teaches hydrogen and fluorine as bioisosteres (Brown, pg. 17), and phenyl and pyridine as ring equivalent bioisosteres (Brown, pg. 19).
As one of ordinary skill in the art would reasonably develop applicant’s compound from Schuppan’s compound 8, claim 8 is prima facie obvious.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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